TIAPRIDAL 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. TIAPRIDAL, 100 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
3. What is Tiapridal and what is it used for
4. Important information before taking Tiapridal
   1. When not to take Tiapridal:
   2. Warnings and precautions
   3. Children and adolescents
   4. Tiapridal with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Tiapridal and other medicines
5. How to take Tiapridal
   1. Overdose of Tiapridal
   2. Missing a dose of Tiapridal
6. Possible side effects
   1. Reporting side effects
7. How to store Tiapridal
8. Contents of the pack and other information
   1. What Tiapridal contains
   2. What Tiapridal looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet: 08/2023

Package Leaflet: Information for the Patient

TIAPRIDAL, 100 mg, tablets

Tiapridum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Tiapridal and what is it used for
• 2. Important information before taking Tiapridal
• 3. How to take Tiapridal
• 4. Possible side effects
• 5. How to store Tiapridal
• 6. Contents of the pack and other information

1. What is Tiapridal and what is it used for

Tiapridal is available in tablet form and contains tiapride as the active substance.
Tiapride is an atypical neuroleptic with anxiolytic and sedative effects. Additionally, it has a beneficial effect on the level of alertness in elderly patients.
Tiapridal is used for the short-term treatment of agitation and aggression in elderly patients.

2. Important information before taking Tiapridal

When not to take Tiapridal:

• if the patient is allergic to tiapride or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a tumor that depends on prolactin levels, such as prolactinoma, prolactin-dependent breast cancer,
• if the patient has a pheochromocytoma,
• if the patient is taking levodopa at the same time (see section: Tiapridal and other medicines).

Warnings and precautions

The patient should contact their doctor immediately:

• in case of fever and/or muscle stiffness during treatment with Tiapridal, especially if taken in combination with other psychiatric medicines.
• if the patient has or has had problems with alcohol (see section: Tiapridal with food, drink, and alcohol).

At the start of treatment, the doctor may order an ECG and blood electrolyte tests (especially potassium levels). Taking tiapride may cause changes in the ECG and increase the risk of serious ventricular arrhythmias, such as torsades de pointes. This risk is higher when there is also bradycardia (heart rate below 55 beats per minute), decreased potassium levels in the blood, and in cases of congenital or acquired QT interval prolongation in the ECG (during concomitant use of medicines that prolong the QT interval). Therefore, the patient should inform their doctor about all recently taken medicines.
In patients with Parkinson's disease, the medicine can only be used if it is absolutely necessary.
Tiapride is excreted from the body by the kidneys, and in patients with renal failure, the dose of the medicine will be reduced by the doctor depending on the assessment of kidney function (creatinine clearance).
In case of liver failure, dose reduction is not necessary.
Tiapride should be used with caution in patients with stroke risk factors and in patients with venous thromboembolism risk factors.
Elderly patients with dementia-related psychosis treated with antipsychotic medicines are at an increased risk of death.
Tiapride may lower the seizure threshold; patients with epilepsy should be under medical supervision during treatment with this medicine.
In elderly patients, tiapride, like other neuroleptics, should be used with special caution due to the risk of consciousness disorders and coma.

Children and adolescents

There is insufficient data on the use of tiapride in children.
Cases of leukopenia, neutropenia, and agranulocytosis have been observed after the use of antipsychotic medicines, including Tiapridal. Unexplained infections or fever may be a sign of abnormal blood counts, and blood tests should be performed immediately.

Tiapridal with food, drink, and alcohol

The medicine should be taken directly before a meal.
During treatment with tiapride, the patient should avoid drinking alcohol and taking medicines containing alcohol.
Consuming alcohol during treatment with Tiapridal may also cause electrolyte balance disorders (mineral imbalance in the blood) and may cause QT interval prolongation (heart rhythm disorders) (see "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Taking Tiapridal is not recommended in pregnant women and women of childbearing age who do not use effective contraception.
If the patient took Tiapridal during the last three months of pregnancy, their child may experience hyperactivity, increased muscle tone, muscle tremors, sleepiness, breathing difficulties, or feeding disorders. If any of these symptoms occur in the child, the patient should contact their doctor.
Breastfeeding
Tiapridal should not be taken during breastfeeding. If the patient is taking Tiapridal, they should discuss alternative breastfeeding options with their doctor.
Fertility
Tiapridal may lead to amenorrhea or anovulation and may decrease fertility in humans.

Driving and using machines

Tiapridal may cause excessive sedation, which may affect the ability to drive vehicles and operate machines during treatment with the medicine.

Tiapridal and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use of tiapride and levodopa is contraindicated.
Concomitant use of tiapride and medicines that may cause torsades de pointes (serious heart rhythm disorders) or QT interval prolongation in the ECG is not recommended. These medicines include:

• medicines that cause bradycardia (heart rate below 55 beats per minute): diltiazem and verapamil, clonidine, guanfacine, digitalis glycosides;
• medicines that decrease potassium levels: diuretics, laxatives, amphotericin B administered intravenously, glucocorticoids, tetracosactide;
• antiarrhythmic medicines of class Ia, such as quinidine, disopyramide;
• antiarrhythmic medicines of class III, such as amiodarone, sotalol;
• other medicines, such as pimozide, sulpiride, haloperidol, thioridazine, methadone, imipramine-derived antidepressants, lithium, bepridil, cisapride (a medicine that stimulates gastrointestinal motility), intravenous erythromycin, intravenous vincamine (a medicine used for cerebral circulation disorders), halofantrine, pentamidine, sparfloxacin.

The doctor should consider the possibility of concomitant use of tiapride and medicines that suppress the central nervous system, such as morphine derivatives (painkillers and antitussives); most antihistamines (histamine receptor antagonists), barbiturates, benzodiazepines, and other anxiolytic medicines, clonidine, and its derivatives.

3. How to take Tiapridal

The dosage may vary and should be adjusted for each patient.
This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
The initial dose is 100 mg per day. If necessary, the dose can be gradually increased to a maximum of 300 mg per day.
The treatment duration should not exceed 28 days.
If the patient feels that the effect of Tiapridal is too strong or too weak, they should consult their doctor.

Overdose of Tiapridal

There is limited data on tiapride overdose. Deaths have been reported after tiapride overdose, mainly in combination with other antipsychotic medicines. The most common symptoms after overdose include dizziness, excessive sedation, coma, decreased blood pressure, and extrapyramidal symptoms (muscle stiffness, reduced facial expressions, slowed movements, restlessness, involuntary muscle contractions, and involuntary movements).
In case of severe overdose, it should always be considered that the patient may also be poisoned with other medicines.
Tiapride is only slightly removed from the body by hemodialysis. Therefore, hemodialysis is not recommended for removing the medicine from the body.
There is no specific antidote for tiapride. Treatment consists of supportive care to maintain basic life functions and close monitoring of heart function until the patient's condition improves.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Tiapridal

In case of missing a dose, the patient should take it as soon as possible, unless it is close to the time for the next dose. The patient should not take two doses of the medicine at the same time or in a short period. In case of doubts, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Tiapridal can cause side effects, although not everybody gets them.
Common (in 1 to 10 patients out of 100):

• dizziness, headaches;
• symptoms like those of Parkinson's disease: tremors, increased muscle tone, hypokinesia (reduced mobility), and salivation. These symptoms usually disappear after administration of anti-Parkinson's disease medicines (e.g., biperiden);
• sleepiness, insomnia, agitation, reduced sensitivity to stimuli (apathy);
• weakness, fatigue;
• hyperprolactinemia (increased prolactin levels in the blood). This symptom disappears after withdrawal of the medicine. Hyperprolactinemia may cause other disorders, such as breast swelling and pain, milk secretion, menstrual disorders in women (painful menstruation, absence of menstruation), gynecomastia (breast enlargement in men), orgasm disorders, and erectile dysfunction in men.

Uncommon (in 1 to 10 patients out of 1,000):

• early dyskinesia, dystonia (spasm, spastic torticollis, oculogyric crises, and trismus), and akathisia (excessive psychomotor activity, restlessness, anxiety). These symptoms usually disappear after administration of anti-Parkinson's disease medicines (e.g., biperiden);
• weight gain;
• disorientation, hallucinations;
• fainting, seizures;
• decreased blood pressure, usually when standing up;
• deep vein thrombosis;
• constipation;
• rash (including erythematous or papular/pustular rash);
• amenorrhea, orgasm disorders.

Rare (in 1 to 10 patients out of 10,000):

• acute dyskinesia. This symptom usually disappears after administration of anti-Parkinson's disease medicines;
• decreased white blood cell count (leukopenia, neutropenia, and agranulocytosis);
• decreased sodium levels in the blood (hyponatremia), a condition called "syndrome of inappropriate antidiuretic hormone secretion" (SIADH);
• late dyskinesia (characterized by rhythmic, involuntary movements, mainly of the tongue and/or facial muscles) after prolonged treatment with the medicine for more than 3 months, similar to other medicines used to treat mental disorders (neuroleptic medicines). In case of such movement disorders, the patient should immediately inform their doctor, who will decide on the necessary actions. Anti-Parkinson's disease medicines should not be taken. In this case, taking anti-Parkinson's disease medicines is ineffective and may even worsen the symptoms;
• malignant neuroleptic syndrome (see also section 2 Warnings and precautions), which is a potentially life-threatening complication;
• loss of consciousness;
• QT interval prolongation, ventricular arrhythmias, such as torsades de pointes, ventricular tachycardia, which can lead to ventricular fibrillation or cardiac arrest and sudden death (see also section 2 Warnings and precautions);
• pulmonary embolism [blood clots in the veins, especially in the legs (with swelling, pain, and redness of the legs), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties], sometimes resulting in death; In case of any of these symptoms, the patient should immediately consult their doctor (see section 2 Important information before taking Tiapridal);
• aspiration pneumonia caused by food particles or vomit entering the lungs;
• breathing difficulties, such as dyspnea, breathing difficulties, shallow breathing, especially when taken with other medicines that have a depressant effect on the central nervous system;
• intestinal obstruction;
• increased liver enzyme activity;
• urticaria;
• increased creatine kinase activity in the blood, muscle weakness, and/or muscle pain;
• breast swelling and pain, milk secretion, gynecomastia, erectile dysfunction.

Additionally, the following side effects have been reported:
Frequency not known (frequency cannot be estimated from the available data):

• withdrawal symptoms in newborns;
• falls.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tiapridal

Storage – no special requirements.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Tiapridal contains

• The active substance of the medicine is 100 mg tiapride (in the form of 111.10 mg tiapride hydrochloride).
• The medicine also contains the following excipients: mannitol, microcrystalline cellulose, povidone, colloidal anhydrous silica, magnesium stearate.

What Tiapridal looks like and contents of the pack

Tiapridal tablets are round, white to ivory, with a cross on one side and the inscription "T100" on the other side.
The pack contains 20 or 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany
Manufacturer:
Delpharm Dijon
6 boulevard de l'Europe
21800 Quetigny
France
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
[email protected]

Date of last revision of the leaflet: 08/2023